Z-1393-2024 Class II Ongoing

Recalled by X-NAV Technologies, LLC — Lansdale, PA

Recall Details

Product Type
Devices
Report Date
April 10, 2024
Initiation Date
March 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
154 units

Product Description

X-Guide Handpiece Adaptor Sleeve 3, Model P010727

Reason for Recall

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.

Code Information

UDI-DI: 00817421021503; Lot: 2306020012, 2310010012